Methods and devices for nebulizing fluids

ABSTRACT

Devices and methods for nebulizing a fluid are described. A replaceable fluid assembly may include a reservoir and a fluid cartridge. The reservoir may be detachable from the fluid cartridge and may be assembled by the prior prior to loading into the nebulizing device.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention is directed to the field of devices fornebulizing fluids. In particular, the nebulizing device of the presentinvention is directed to an inhalation device for delivering a nebulizedfluid.

[0003] The present invention is also directed to devices and methods forstoring and delivering fluids to be nebulized.

SUMMARY OF THE INVENTION

[0004] The present invention provides a nebulizing device which ispreferably a handheld nebulizing device for inhalation of the nebulizedfluid. The device has a mouthpiece through which the user inhales thenebulized fluid. The nebulizing element is preferably a vibratingelement with holes through which the fluid is ejected although othersuitable nebulizing elements may be used without departing from numerousaspects of the invention.

[0005] The fluid is held in a container which holds a number of doses ofthe fluid. The container delivers the fluid to a reservoir. Thereservoir is designed to minimize the residual volume in the reservoir.The inner surface of the reservoir is preferably hydrophobic toencourage fluid to flow downward to the nebulizing element. Thereservoir is also preferably tear-drop shaped and has a smooth innersurface which is free of seams and corners to further encourage downwardflow. The container and reservoir may be replaced independently or atthe same time. The reservoir and container may also be a single unit ormay be separate units mounted to the device by the user.

[0006] The reservoir also has a collection area located adjacent to thevibrating element where a final volume of fluid accumulates. The finalvolume is drawn over the holes in the vibrating element when thevibrating element is vibrated thereby reducing the residual volume. Thereservoir is also designed so that the nebulizing element is positionedat a relatively low hydrostatic position when the nebulizer ispositioned in a preferred operating orientation. For example, thenebulizing element may be positioned so that less than 25%, and evenless than 10%, of the volume of the reservoir is positioned below thenebulizing element.

[0007] The reservoir also has one or more vent holes for smooth fluiddelivery into the reservoir during filling and out of the reservoir whenthe fluid is being nebulized. The vent hole is sized to prevent thefluid from escaping therethrough.

[0008] The fluid path between the container and reservoir includes avalve which prevents contamination of the container and fluid path. Thevalve maintains the sterility of the container so that the containerdoes not need to be pierced a number of times as may otherwise benecessary. The valve may be positioned at a wall of the reservoir sothat the valve isolates the entire fluid path together with thecontainer.

[0009] Various aspects of the present invention are also directed to acontainer. The container is similar to a standard vial with the additionof a specialized connector. The connector mates with the nebulizingdevice and, in another aspect, may mate with the reservoir as well. Theconnector has a protrusion which engages an L-shaped slot in the devicefor a bayonette-type connection. The connector also has a number of tabsor hooks which engage the reservoir to lock the reservoir to thecontainer.

[0010] The mouthpiece may be separable from the rest of the housing. Thenebulizing element may also be contained within the mouthpiece so thatthe nebulizing element may be cleaned along with the mouthpiece. Themouthpiece also has a port which receives a pressure sensing conduit.The pressure sensing conduit leads from a mouthpiece chamber to apressure sensor. The pressure sensor is used for breath-actuation of thedevice by sensing the drop in pressure when the user inhales on themouthpiece.

[0011] These and other aspects of the invention are disclosed anddescribed in the following description, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0012]FIG. 1 shows a nebulizer.

[0013]FIG. 2 shows a fluid assmebly formed by a reservoir and acontainer.

[0014]FIG. 3 shows the nebulizer with a mouthpiece and fluid assemblyremoved.

[0015]FIG. 4 show the fluid assembly mounted to the nebulizer with themouthpiece removed.

[0016]FIG. 5 shows the container.

[0017]FIG. 6 is a perspective, cross-sectional view of the reservoir.

[0018]FIG. 7 is the perspective view of device with the mouthpieceremoved.

[0019]FIG. 8 is a perspective view of FIG. 7 with the mouthpieceattached to the housing.

[0020]FIG. 9 is a cross-sectional view of the nebulizer with thereservoir empty.

[0021]FIG. 10 is a cross-sectional view of the nebulizer with thereservoir filled with a volume of fluid.

[0022]FIG. 11 shows the nebulizing element delivering the nebulizedfluid through the mouthpiece.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0023] Referring to FIGS. 1-8, a nebulizing device 2 is shown. Thenebulizing device 2 is preferably a hand-held inhalation device althoughvarious aspects of the invention may be practiced with any othernebulizing device or inhalation device. The nebulizing device 2 has ahousing 4 which includes a mouthpiece 6 through which the user inhales anebulized fluid. The fluid is nebulized by a nebulizing element 8 andthe nebulized fluid is entrained in air drawn into the device 2 throughair inlet openings 10 in the mouthpiece 6.

[0024] The fluid to be nebulized is stored in a container 12, such as avial 14, which preferably holds a number of doses of the fluid. Thecontainer 12 is removed and replaced as necessary. The user selects adose size or amount and delivers the dose from the container 12 to areservoir 14, which holds the fluid. The reservoir 14 may be removed andreplaced together with or separate from the container 12 as explainedbelow.

[0025] The container 12 has a piston 16, which is moved by a dosingmechanism 18 to dispense a volume of the fluid. The dosing mechanism 18may be any suitable dosing mechanism such as the dosing mechanisms forinsulin pen mechanisms. The dosing mechanism 18 is operated with adosing control 20 which the user operates to select and deliver aquantity of fluid to the reservoir 14. The housing 4 has a window 20 toview the amount of fluid in the container 12.

[0026] The container 12 has a body 22 similar to a standard vial. Thecontainer 12 does differ from a standard vial in that the container 12has a connector 23, such as a collar 24, which mates with the reservoir14 and the nebulizer 2. The connector 23 helps to prevent the user fromloading the wrong fluid into the nebulizer 2. To this end, the connector23 has a bayonet-type connection with the nebulizer 2. The connector 23has three projections 26 extending from a cylindrical body 28. Theprojections register and slide within L-shaped 30 slots in the nebulizer2. The container 12 is loaded into the device 2 by pushing downward andthen rotating the collar 24 to secure the collar 24, and thereforecontainer 12, to the device 2. The slots 30 may have a raised-portion ordetent to lock the projection in the slot 30. The position, size,spacing and orientation of the projections 26 and corresponding slots 30may be altered for different fluids to prevent use of the improperfluid. The device 2 may also have a sensor 32 which detects properengagement of the projection 26 within the slot 30 before the device 2will dispense fluid. The container 12 may, of course, have any suitableconnection with the nebulizer 2 which helps to prevent use of theimproper fluid.

[0027] The container 12 also locks together with the reservoir 14 toprovide a secure engagement with the reservoir. When the container 12 ismounted to the reservoir 14, a needle 40 pierces the container 12. Thecontainer 12 also has three tabs or hooks 42 which lock together withmating connectors 44 on the reservoir 14. The tabs 42 are located about120 degrees apart and each have a recess 44 and a shoulder 46 whichengage complementary features on a connector 43 on the reservoir 14. Thecontainer 12 and reservoir 14 may, of course, mount to one another inany other suitable manner and the features may be altered for differentfluids.

[0028] The container 12 and reservoir 14 form a fluid assembly 48. Thecontainer 12 is preferably mounted to the reservoir 14 by the userimmediately before loading the container 12 and reservoir 14.Alternatively, the container 12 and reservoir 14 may be loadedsequentially. For example, the container 12 could be mounted to thedevice 2 followed by mounting the reservoir 14 to the container 12. Thefluid assembly 48 may also be provided as a single unit which the userreplaces all at once.

[0029] The reservoir 14 has an opening 50 which delivers the fluid tothe nebulizing element 8. The opening 50 is oriented to form a feedangle of about 5 to 30 degrees, and may be about 15 degrees, relative tothe longitudinal axis L of the container 12 as defined by the container12 body. The opening 50 also may have a diameter of about 0.05 to 0.25inch and may be about 0.15 inch. The opening 50 size and feed angleprovide smooth delivery of the fluid from the reservoir 14 to thenebulizing element 8 particularly when the nebulizing element 8 isoriented somewhat upright.

[0030] The fluid travels along a fluid path 52 between the container 12and reservoir 14. The fluid path 52 includes the needle 40 and a channel54 leading from the needle 40 to the reservoir 14. The fluid path 52may, of course, be formed in any other manner including a simple lumenor tube extending between the container 12 and reservoir 14.Furthermore, the fluid coupling between the container 12 and reservoir14 may be any other suitable coupling other than the needle 40.

[0031] The fluid path 52 also includes a valve 54 which preventscontamination of the container 12. The valve 54 eliminates the need topierce the container 12 a number of times as may be necessary tomaintain sterility if the valve were not provided. The valve 54 may be aone-way valve such as a slit valve, ball valve or duckbill valve. Thevalve 54 is preferably positioned to protect the entire fluid pathbetween the container 12 and reservoir 14. To this end, the valve 54 maybe positioned at the end of the fluid path 52 such as at a wall 56 ofthe reservoir 14. The valve 54 may also be positioned at a relativelylow hydrostatic position relative to the reservoir 14 such that lessthan 25% of the reservoir 14, and more preferably less than 10%, ispositioned hydrostatically below the valve 54. In this manner, theresidual fluid volume in the reservoir 14 may be reduced since the valve54 position can reduce the wetted surface of the reservoir 14 ascompared to a valve positioned to dispense the fluid at a higherposition in the reservoir. Of course, the valve 54 may be positioned atan elevated position in the reservoir 14 without departing from theinvention. The valve 54 may also direct the fluid at the nebulizingelement 8. The valve 54 may direct a stream of fluid at the nebulizingelement 8 so that air in the reservoir 14 near the nebulizing element 8is actively removed. A problem which can occur when delivering fluid tothe nebulizing element is that air can be trapped near the nebulizingelement which can inhibit proper functioning of the device. Theorientation of the valve 54 and the ability of the valve 54 to deliver astream of fluid together reduce the risk of trapping air around thenebulizing element 8.

[0032] The reservoir 14 has an inner wall 71 that has a tear-drop shapeand is substantially free of corners, seams and edges to encourage fluiddrainage. The reservoir 14 has a backwall 60 which forms an angle ofabout 20 to 70 degrees with respect to horizontal when the device isheld in a preferred operating orientation. The inner wall 62 of thereservoir 14 is also preferably hydrophobic, but may be hydrophyllicdepending upon the application and particular fluid, to further reducethe residual volume. The reservoir 14 may also have a relatively smallvolume to minimize the surface area of the reservoir 14. The tear-dropshape, smooth interior wall, angled backwall 60 and hydrophobic surfaceall encourage liquid in the reservoir 14 to flow downward toward thenebulizing element 8 thereby minimizing the residual fluid volume.

[0033] The nebulizing element 8 may be angled away from the reservoir 14at an angle of about 0-45 degrees relative to vertical and may be about15 degrees when the device is in the preferred operating orientation.The reservoir 14 may be made in any suitable manner and with anysuitable materials. For example, the reservoir 14 may be made out ofpolypropylene and formed by injection molding. The nebulizing element 8may be oriented in any other manner and may be any type of nebulizingelement.

[0034] The mouthpiece 6 may be removable to load and remove thecontainer 12 and/or reservoir 14. Removal of the mouthpiece 6 alsopermits cleaning of the mouthpiece 6 and nebulizing element 8. Thenebulizing element 8 may be cleaned or removed after each use or at anypredetermined interval such as, for example, after a predeterminednumber of containers 12 and/or reservoirs 14 have been used. Themouthpiece 6 or nebulizing element 8 may even be removed and replacedwith each container 12 or assembly 48. The mouthpiece 6 may be mountedwith a suitable connection such as a snap-fit connection or latch withthe rest of the housing.

[0035] The mouthpiece 6 has the air inlet opening 10, preferably anumber of openings 10, which permit introduction of air to entrain thenebulized fluid for inhalation by the user. The nebulized fluid isentrained in the air entering a mouthpiece chamber 63 and the nebulizedfluid is inhaled by the user when the user inhales on the mouthpiece.

[0036] The nebulizing element 8 may include a vibrating assembly 80. Thevibrating assembly 80 includes a piezoelectric element 82 mounted to asubstrate 84. The substrate 84 may be cup-shaped 86 or may have anyother suitable shape such as a flat-ring or plate. A vibrating element88 with a number of holes 90 is mounted to the substrate 84. Thevibrating element 88 is preferably dome-shaped and the holes 90 may betapered. The vibrating element 88 and assembly 80 may, of course, be anyother suitable element such as a flat-plate, thin mesh or flexiblemembrane without departing from the scope of the invention. Furthermore,various aspects of the invention may be practiced independent of theparticular nebulizing method and device.

[0037] The substrate 84 is coupled to the mouthpiece directly or by amounting element 92 which secures the vibrating assembly 80 to thehousing 4 and specifically the mouthpiece 6. The vibrating assembly 80,via the mounting element 92, is coupled to the housing 4 by a flexibleconnection 94 such as a resilient connection 95. The connection 94 maybe formed in part by a spring, foam, or elastomeric element disposedbetween the vibrating assembly 80 and housing 4. In the particularembodiment shown, an elastomeric element 96 having an oval cross-sectionis shown although a C-shaped cross-section or other suitable shape maybe used such as U-shaped. The flexible or resilient connection 94 canreduce dampening of the vibrating assembly as compared to rigidconnections with the mouthpiece or housing 6.

[0038] The resilient connection 95 also provides a modest closing forceon a fluid seal 98 between the nebulizing element 8 and reservoir 14.The closing force created by the resilient connection 95 helps toprevent fluid from leaking out of the seal 98 between the reservoir 14and nebulizing element 8. The seal 98 is formed by a sealing element100, such as an o-ring on the mounting element 92, and a complementarysealing element 102, such as a groove on the reservoir 14. Theconnection 94 naturally biases the sealing elements 100, 102 together inthat the connection 94 is slightly compressed when the reservoir 14 ismounted. The proper allignment of the reservoir 14 is achieved when themouthpiece 6 registers with the rest of the housing 4.

[0039] The mounting element 92 may also engage the vibrating assembly80, such as the vibrating element 88, and direct fluid to the vibratingelement 88. The mounting element 92 may engage the vibrating element 88with any suitable connection. For example, the mounting element may beglued to the vibrating element 88 or may have an o-ring which engagesthe vibrating element. As mentioned above, the vibrating element isgenerally oriented within 45 degrees of vertical, and preferably about15 degrees, during operation but may be oriented at any other anglewithout departing from the invention.

[0040] The device 2 is preferably breath-actuated in any suitablemanner. In the preferred embodiment, a pressure sensor 110, such as apressure transducer 112, measures pressure in the mouthpiece chamber 114so that when the user inhales on the mouthpiece 6 the sensor 110 detectsthe pressure drop and triggers the nebulizing element 8 at a triggerpressure. The pressure sensor 110 may be mounted to the mouthpiece 6 butis preferably mounted to the body of the device 2. A pressure sensingconduit 116 extends to a rear chamber 118 of the device 2 where thepressure sensor 110 is mounted. A pressure sensing port 118 in themouthpiece 6 receives the conduit 116 to provide pressure communicationbetween the mouthpiece chamber 63 and pressure sensor 110 via theconduit 116.

[0041] Operation of the device is now described. The user detaches themouthpiece and loads the fluid assembly into the device. The fluidassembly may be formed by the container and reservoir which are attachedtogether by the user or mounted in sequence to the device. Once thecontainer and reservoir are attached together, the interlocking featuremay prevent disassembly and thus prevent improper usage of the deviceand parts thereof. The device may be primed in any suitable manner. Forexample, a volume of fluid equal to or just larger than the fluid pathmay be delivered when the container is loaded or when the first dose isdelivered from a particular container. Alternatively, fluid may simplybe delivered from the container until fluid is sensed in the reservoir.

[0042] When the user is prepared to inhale the nebulized fluid, the useroperates the dosing controls to select and deliver a volume of fluidfrom the container to the reservoir. The dosing mechanism moves thepiston to move fluid through the fluid path, out the valve and into thereservoir as shown in FIGS. 9 and 10. The user then operates the deviceby simply inhaling on the mouthpiece. When the user inhales, thepressure sensor detects the drop in pressure until the trigger pressureis reached at which time the nebulizing element is activated. Air isdrawn into the chamber through the inlet openings and the nebulizedfluid is entrained in the air which is inhaled by the user. The devicecontinues to nebulize fluid while the user continues to inhale. Thisprocess is repeated until all of the solution has been nebulized. Thedevice may also measure, detect or calculate when all of the fluid inthe reservoir has been nebulized in any suitable manner. For example,the device may deactivate the nebulizing element by measuring theresonant frequency of the vibrating element before fluid is deliveredand deactivating the nebulizing element just before the dry resonantfrequency is reached again.

[0043] The invention has been described with respect to various specificembodiments but it can be appreciated that various modifications may bemade without departing from the scope of the invention.

What is claimed is:
 1. A method of delivering a nebulized fluid forinhalation, comprising the steps of: providing a nebulizing device, areservoir and a container, the reservoir and container beingreplaceable; delivering a volume of fluid from the container to thereservoir; using the nebulizing element to nebulize the volume of fluid;repeating the delivering and using steps a number of times with the samecontainer; removing and replacing the container; and removing andreplacing the reservoir.
 2. The method of claim 1, wherein: theproviding step is carried out with the nebulizing device having avibrating element with a plurality of holes, the reservoir holding afluid in contact with the vibrating element.
 3. The method of claim 1,wherein: the removing and replacing steps are carried out with thereservoir being mounted to the container by the user which is followedby the user mounting both components together into the nebulizingdevice.
 4. The method of claim 1, wherein: the providing step is carriedout with reservoir having a needle which penetrates the containerthereby providing a fluid path between the container and the reservoir.5. The method of claim 1, wherein: the providing step is carried outwith a one-way valve positioned along a fluid path between the containerand the reservoir.
 6. The method of claim 5, wherein: the providing stepis carried out with the nebulizing device having a vibrating assembly,the vibrating assembly having a plurality of holes therein; and thedelivering step is carried out with the valve directing the fluid at thevibrating assembly; and the using step is carried out with the fluidpassing through the holes in the vibrating assembly.
 7. The method ofclaim 5, wherein: the delivering step is carried out with the valvedelivering a stream of the fluid.
 8. The method of claim 7, wherein: thedelivering step is carried out with the stream of fluid being directedat a vibrating assembly of the nebulizing device.
 9. The method of claim4, wherein: the providing step is carried out with the valve positionedat the end of the fluid path so that the valve leads directly into thereservoir.
 10. The method of claim 1, further comprising the step of:removing a mouthpiece before the removing steps to permit at least oneof the reservoir and the container to be removed and replaced.
 11. Themethod of claim 10, wherein: the removing steps are carried out with thereservoir and the container being separate units.
 12. The method ofclaim 11, wherein: the removing steps are carried out with the reservoirbeing mounted to the container by the user.
 13. A nebulizer fornebulizing a fluid for inhalation by a user, comprising: a housing; anebulizing element contained in the housing; a container which holds anumber of doses of the fluid to be nebulized, the container beingremovable and replaceable; a reservoir coupled to the housing, thereservoir holding a volume of the fluid in contact with the nebulizingelement, the reservoir being removable and replaceable; and a fluid pathbetween the container and the reservoir through which the volume offluid is delivered from the container to the reservoir.
 14. Thenebulizer of claim 13, wherein: the nebulizing element includes avibrating element with a plurality of holes; and the reservoir holds thefluid in contact with the vibrating element.
 15. The nebulizer of claim13, wherein: the container and fluid path are removed and replaced withthe reservoir.
 16. The nebulizer of claim 13, wherein: the reservoir ismounted to the container by the user.
 17. The nebulizer of claim 13,wherein: the fluid path includes a needle which penetrates thecontainer.
 18. The nebulizer of claim 13, wherein: the fluid pathincludes a one-way valve positioned between the container and thereservoir.
 19. The device of claim 18, wherein: the nebulizing elementhas a vibrating assembly with a plurality of holes, the fluid passingthrough the holes in the vibrating assembly; and the valve directing thefluid at the vibrating assembly.
 20. The device of claim 18, wherein:the valve delivers a stream of the fluid.
 21. The device of claim 20,wherein: the nebulizing element has a vibrating assembly having avibrating element with a plurality of holes; and the valve delivers thestream at the vibrating assembly.
 22. The nebulizer of claim 13, furthercomprising: a removable mouthpiece, the mouthpiece being removed topermit at least one of the reservoir and container to be removed andreplaced.
 23. The nebulizer of claim 22, wherein: the mouthpiece holdsthe nebulizing element.
 24. The nebulizer of claim 13, wherein: thenebulizing element is removable.
 25. A removable and replaceablereservoir which holds and delivers a fluid to a nebulizer, comprising: areservoir having a chamber which has an opening therein, the openingbeing configured to mate with a nebulizing assembly, the opening havinga diameter of 0.05 to 0.25 inch and a connector for coupling to agenerally cylindrical fluid container, the connector being configured toorient the cylindrical fluid container along an axis of symmetry, theaxis of symmetry forming an angle of 0 to 45 degrees relative to theopening.
 26. The reservoir of claim 25, further comprising: a fluid pathleading from the reservoir to the connector; the connector also having afluid coupling which provides fluid communication with the containerwhen the container is mounted to the reservoir.
 27. The reservoir ofclaim 26, wherein: the fluid coupling is a needle which penetrates aseptum of the container when the container is mounted to the reservoir.28. The reservoir of claim 26, further comprising: a one-way valvepositioned along the fluid path, the one-way valve permitting flow fromthe container to the reservoir and preventing flow in the reversedirection.
 29. The device of claim 28, wherein: the nebulizing elementhas a vibrating and the valve directing the fluid at the vibratingassembly.
 30. The device of claim 29, wherein: the vibrating assemblyhas a plurality of holes, the fluid passing through the holes in thevibrating assembly.
 31. The device of claim 28, wherein: the valvedelivers a stream of the fluid.
 32. The device of claim 31, wherein: thenebulizing element has a vibrating assembly having a vibrating elementwith a plurality of holes; and the valve delivers the stream at thevibrating assembly.
 33. The reservoir of claim 25, wherein: the open endof the reservoir is oriented at an angle of about 15 degrees relative tothe axis of symmetry of the connector.
 34. The reservoir of claim 25,wherein: the open end of the reservoir has a diameter of about 0.15inch.
 35. The reservoir of claim 25, wherein: the reservoir has ahydrophobic inner surface.
 36. The reservoir of claim 25, wherein: thereservoir has a smooth inner surface which is substantially free ofcorners and seams.
 37. The reservoir of claim 25, wherein: the reservoirhas a tear-drop shape.
 38. A removable and replaceable reservoir whichholds and delivers a fluid to a nebulizer, comprising: a reservoirhaving an open end, the open end sealing with a nebulizing assembly andhaving a diameter of about 0.15 inch, the open end generally lying in aplane; a fluid path leading from the container to the reservoir; and aconnector for coupling to a generally cylindrical fluid container, theconnector being configured to orient the cylindrical fluid containeralong an axis of symmetry; wherein axis of symmetry forms an angle withthe plane of about 15 degrees.
 39. A fluid vial, comprising: a vialhaving a body and a chamber which holds a fluid; a piston positioned inthe body and slidable within the body to force fluid from the chamber; aconnector having at least one protrusion extending radially outwardwhich engages a complementary slot in a fluid delivery device.
 40. Thefluid vial of claim 39, wherein: the connector is a collar positionedaround a cap on the body.
 41. The fluid vial of claim 39, wherein: theconnector has three protrusions.
 42. The fluid vial of claim 39,wherein: the protrusions have a substantially square cross-sectionalshape.
 43. The fluid vial of claim 39, further comprising: a lockingconnector which locks to a reservoir which holds a volume of the fluid.44. The fluid vial of claim 45, wherein: the locking connector has atleast one tab extending longitudinally from the end of the vial.
 45. Thefluid vial of 43, wherein: the locking connector has a radially innerrecess with a shoulder positioned distally of the recess.
 46. Acontainer and reservoir assembly, comprising: a container having apiston, the container having a chamber which holds a fluid, the pistonbeing movable within the housing to force fluid from the chamber; areservoir coupled to the container; and a fluid path between thecontainer and reservoir.
 47. The assembly of claim 46, wherein: thereservoir has an open end which engages a nebulizer to deliver the fluidin the reservoir to the nebulizer.
 48. The assembly of claim 47,wherein: the open end of the reservoir has a diameter of 0.05 to 0.25inch
 49. The assembly of claim 47, wherein: the open end of thereservoir is oriented at an angle of about 15 degrees relative to alongitudinal axis of the container.
 50. The assembly of claim 46,wherein: the fluid path includes a one-way valve which permits fluidflow into the reservoir from the container.
 51. The device of claim 50,wherein: the nebulizing element has a vibrating assembly with aplurality of holes, the fluid passing through the holes in the vibratingassembly; and the valve directing the fluid at the vibrating assembly.52. The device of claim 50, wherein: the valve delivers a stream of thefluid.
 53. The device of claim 50, wherein: the nebulizing element has avibrating assembly having a vibrating element with a plurality of holes;and the valve delivers the stream at the vibrating assembly.
 54. Theassembly of claim 50, wherein: the one-way valve is a slit-valve. 55.The assembly of claim 50, wherein: the one-way valve directs the fluidat the nebulizing element.
 56. The assembly of claim 55, wherein: theone-way valve directs the fluid at the nebulizing element as a stream ofliquid.
 57. The assembly of claim 50, wherein; the valve is positionedat the end of the fluid path.
 58. The assembly of claim 46, wherein thecontainer and reservoir are separate components which are coupledtogether by the user.
 59. A removable and replaceable container andreservoir assembly for a nebulizer, comprising: a container having apiston, the container having a housing which houses a fluid, the pistonbeing movable within the housing to force fluid from the container, thepiston moving generally along a longitudinal axis of the housing; areservoir which holds liquid to be nebulized, the reservoir having anopen end which delivers fluid to the nebulizer when the reservoir ismounted to the device, the open end of the reservoir has a diameter of0.05 to 0.25 inch, the open end of the reservoir being oriented at anangle of about 0 to 45 degrees relative to the longitudinal axis of thehousing; and a fluid path between the container and reservoir.
 60. Theassembly of claim 59, wherein: the fluid path includes a one-way valvewhich permits fluid flow toward the reservoir.
 61. The assembly of claim59, wherein: the reservoir is mounted to the container by the user whenthe assembly is replaced in the nebulizer.
 62. A mouthpiece for anebulizing device, comprising: a connector configured to be coupled to ahousing of the nebulizing device; a nebulizing element positioned toemit a nebulized fluid into the chamber; a chamber having at least oneair inlet opening through which a user inhales ambient air, the airinlet opening being positioned to produce an air flow in the chamberwhich entrains the fluid nebulized by the nebulizing element.
 63. Themouthpiece of claim 62, further comprising: an electrical connectorwhich electrically couples the mouthpiece to the nebulizing device whenthe mouthpiece is mounted to the nebulizing device with the connector.64. The mouthpiece of claim 62, wherein: the mouthpiece has a pressuremeasurement port for measuring the pressure in the chamber.
 65. Themouthpiece of claim 64, wherein: the pressure measurement port isconfigured to be coupled to a pressure measurement conduit in thenebulizing assembly.
 66. The mouthpiece of claim 62, wherein: thenebulizing element is mounted to the housing with a resilientconnection.
 67. The mouthpiece of claim 62, wherein: the nebulizingelement includes a vibrating element with holes, the nebulized fluidbeing emitted through the holes in the vibrating element when thevibrating element is vibrated.
 68. The mouthpiece of claim 67, wherein:the vibrating element has a front side leading to the chamber so thatnebulized fluid passing through the holes enters the chamber, thevibrating assembly also having a backside which receives the fluid to benebulized.
 69. The mouthpiece of claim 67, further comprising: a fluidconnector configured to mate with a corresponding connector on a fluidassembly which contains a fluid, the fluid connector directing fluid tothe backside of the vibrating element.
 70. The mouthpiece of claim 62,wherein: the nebulizing element is oriented at an angle of about 0-45degrees relative to horizontal during operation.
 71. A mouthpiece for anebulizing device, comprising: a connector configured to be coupled to ahousing of the nebulizing device; a nebulizing element positioned toemit a nebulized fluid into the chamber; a chamber having at least oneair inlet opening through which a user inhales ambient air, the airinlet opening being positioned to produce an air flow in the chamberwhich entrains the fluid nebulized by the nebulizing element. anelectrical connector which electrically couples the mouthpiece to thenebulizing device when the mouthpiece is mounted to the nebulizingdevice; a pressure measurement port configured to be coupled to apressure measurement conduit in the nebulizing assembly.
 72. Themouthpiece of claim 71, wherein: the nebulizing element is mounted tothe housing with a resilient connection.
 73. The mouthpiece of claim 71,wherein: the nebulizing element includes a vibrating element with holes,the nebulized fluid being emitted through the holes in the vibratingelement when the vibrating element is vibrated.
 74. The mouthpiece ofclaim 73, wherein: the vibrating element has a front side leading to thechamber so that nebulized fluid passing through the holes enters thechamber, the vibrating assembly also having a backside which receivesthe fluid to be nebulized.
 75. The mouthpiece of claim 73, furthercomprising: a fluid connector configured to mate with a correspondingconnector on a fluid assembly which contains a fluid, the fluidconnector directing fluid to the backside of the vibrating element. 76.A nebulizing device for nebulizing a fluid, comprising: a housing; avibrating assembly contained within the housing, the vibrating assemblyincluding a nebulizing element and a piezoelectric element, thenebulizing element having a plurality of holes through which thenebulized fluid exits, the piezoelectric element being coupled to thenebulizing element to vibrate the nebulizing element; and a resilientmounting which couples the vibrating assembly to the housing.
 77. Thenebulizing device of claim 76, further comprising: a fluid connectorcoupled to the resilient mounting, the resilient mounting providing aclosing force between the fluid connector and a removable andreplaceable fluid assembly which holds the fluid.
 78. The nebulizingdevice of claim 76, wherein: the resilient mounting includes an elasticmaterial.
 79. The nebulizing device of claim 78, wherein: the elasticmaterial is an elastomeric material.
 80. A nebulizing device fordelivering nebulized fluids for inhalation, comprising: a housing havinga mouthpiece for inhalation of a nebulized fluid by the user; avibrating element mounted within the housing, the vibrating elementhaving a plurality of holes therein through which the nebulized fluidemerges; a container which contains a fluid; a reservoir which holds avolume of the fluid delivered from the container; and a fluid pathbetween the container and the reservoir to deliver fluid from thecontainer to the reservoir.
 81. The nebulizing device of claim 80,wherein: the container is removable and replaceable.
 82. The nebulizingdevice of claim 80, wherein: the reservoir is removable and replaceable.83. The nebulizing device of claim 80, wherein: the reservoir andcontainer are replaced at the same time.
 84. The nebulizing device ofclaim 80, wherein: the reservoir and container are coupled together. 85.The nebulizing device of claim 85, wherein: the reservoir is mounted tothe container by the user.
 86. The nebulizing device of claim 80,wherein: the vibrating element is generally oriented 0-45 degrees fromvertical.
 87. The nebulizing device of claim 80, wherein: the reservoirhas an inner surface which is hydrophobic.
 88. The nebulizing device ofclaim 80, wherein: the inner surface of the reservoir is substantiallysmooth and free of seams and corners.
 89. The nebulizing device of claim88, wherein: the inner surface of the reservoir is tear-drop shaped. 90.The nebulizing device of claim 80, wherein: the vibrating element isvibrated by a piezoelectric element.
 91. The nebulizing device of claim80, wherein: the reservoir has a collection area located adjacent to thevibrating element where a final drop of the fluid in the reservoir to bedelivered accumulates, wherein the final drop accumulated in thecollection area is drawn over the holes when the vibrating element isvibrated.
 92. The nebulizing device of claim 80, wherein: the reservoirhas at least one vent hole therein, the vent hole being sized to preventthe fluid from escaping therethrough due to surface tension adhesion.93. The nebulizing device of claim 86, wherein: the vent hole is formedby a hole in the reservoir.
 94. The nebulizing device of claim 80,wherein: the fluid path includes a needle which pierces the container.95. The nebulizing device of claim 80, wherein: the fluid path includesa one-way valve which permits flow in the direction of the reservoir andprevents flow back toward the container.
 96. The device of claim 95,wherein: the nebulizing element has a vibrating assembly with aplurality of holes, the fluid passing through the holes in the vibratingassembly; and the valve directing the fluid at the vibrating assembly.97. The device of claim 95, wherein: the valve delivers a stream of thefluid.
 98. The device of claim 95, wherein: the nebulizing element has avibrating assembly having a vibrating element with a plurality of holes;and the valve delivers the stream at the vibrating assembly.
 99. Amethod of nebulizing a fluid, comprising the steps of: providing anebulizer having a nebulizing element and a reservoir, the nebulizingelement having a vibrating element with a plurality of holes therein,the nebulizer also having a container and a fluid path, the fluid pathleading from the container to the reservoir and having a one-way valvewhich permits fluid flow into the reservoir; and delivering a volume offluid to the reservoir from the container so that the fluid accumulatesin the reservoir and in contact with the plurality of holes; andactivating the nebulizer to nebulize the fluid in the reservoir, thevibrating element being vibrated so that the fluid in the reservoir isdispensed through the holes in the vibrating element.
 100. The method ofclaim 99, wherein: the providing step is carried out with the nebulizingelement positioned at a hydrostatic location relative to the reservoirsuch that less than 25% of the volume of the reservoir lies below thenebulizing element.
 101. The method of claim 99, wherein: the providingstep is carried out with the nebulizing element positioned at ahydrostatic location relative to the reservoir such that less than 10%of the volume of the reservoir lies below the nebulizing element. 102.The method of claim 99, wherein: the valve is positioned at ahydrostatic location relative to the reservoir such that less than 25%of the volume of the reservoir lies below the valve.
 103. The method ofclaim 99, wherein: the delivering step is completed before theactivating step is started.
 104. The method of claim 99, wherein: theproviding step is carried out with the valve being positioned at a wallof the reservoir so that the valve isolates the entire fluid path. 105.The method of claim 104, wherein: the providing step is carried out withthe valve being a slit valve.
 106. The method of claim 99, wherein: thedelivering step is carried out before the activating step so that thevolume accumulates in the reservoir prior to the activating step. 107.The method of claim 99, wherein: the providing step is carried out withthe vibrating element being generally oriented 0-45 degrees relative tovertical.
 108. The method of claim 99, wherein: the providing step iscarried out with the nebulizing element being vibrated by apiezoelectric element.
 109. The method of claim 99, wherein: theproviding step is carried out with the reservoir having a collectionarea located adjacent to the nebulizing element; the activating step iscarried out with a final drop of fluid in the reservoir accumulating inthe collection area, wherein the final drop is drawn over the holes inthe nebulizing element.
 110. The method of claim 99, wherein: theproviding step is carried out with an inner surface of the reservoirbeing hydrophobic.
 111. The method of claim 99, wherein: the providingstep is carried out with the inner surface of the reservoir beingsubstantially smooth and free of seams and corners.
 112. The method ofclaim 99, wherein: the providing step is carried out with the reservoirhaving a tear-drop shape.
 113. The method of claim 99, wherein: theproviding step is carried out with the container holding a number ofvolumes of the liquid and being replaceable.
 114. The method of claim99, wherein: the providing step is carried out with the container andthe reservoir both being replaceable.
 115. The method of claim 114,wherein: the container is mounted to the reservoir and the container andreservoir are removed and replaced at the same time.
 116. The method ofclaim 99, wherein: the fluid path includes a needle which pierces thecontainer.
 117. The method of claim 99, wherein: the providing step iscarried out with the nebulizing device having a vibrating assembly, thevibrating assembly having a plurality of holes therein; and thedelivering step is carried out with the valve directing the fluid at thevibrating assembly; and the using step is carried out with the fluidpassing through the holes in the vibrating assembly.
 118. The method ofclaim 99, wherein: the delivering step is carried out with the valvedelivering a stream of the fluid.
 119. The method of claim 99, wherein:the delivering step is carried out with the stream of fluid beingdirected at a vibrating assembly of the nebulizing device.